I. Field of the Invention
This invention relates to medical devices such as heart pacemakers, defibrillators, leads and the like. More specifically, the invention relates to the creation and maintenance of records related to such medical devices to ensure proper medical care, to assist in medical research, and to comply with existing governmental regulations.
II. Description of the Related Art
The use of medical devices to treat a variety of medical conditions has increased dramatically over the past 40 years. Such devices, and particularly cardiac rhythm management devices, have become more sophisticated. Many features of these and other electronic implantable medical devices are now programmable so that the functionality of such devices can be uniquely tailored to address the specific needs of the patient who is the recipient of the implant. To ensure proper ongoing care of the patient, it is important to accurately document for future reference certain information related to the patient, the implantable device, and the manner in which the device is being used.
The state of medical care would not be as advanced as it is today were it not for the meticulous collection and analysis of patient data to determine the efficacy of various treatment methods. Such data not only assists medical researchers and medical providers to determine which courses of treatment work best, but also provide important information to determine what new courses of treatment might prove to be effective. Thus, researchers and companies involved in the development of medical products have a real need for high quality data.
With the advent of new medical technologies, various government agencies have required better recordkeeping and reporting. The current state of the art typically requires the medical provider to select one or more forms, manually complete the forms, make the requisite number of copies of the form, find the patient file and place a copy in the file, give copies to the patient, and mail copies to the device manufacturer. The creation of such records and reporting of data can thus be a time-consuming venture that greatly increases the cost of providing medical services and products to the public. Thus, a real need has developed for a way to provide greater efficiency in the recording and reporting of data.
State of the art implantable cardiac rhythm management devices and programmers for such devices are all capable of storing various types of data in their memories. The programmers have been used to retrieve data from the implantable device. The programmers have also been used to display and print various reports based on such data. However, the capabilities of such implantable devices and programmers have never been used to select the proper warranty and registration form for the particular implanted device, complete the form, print copies of the form or otherwise transmit the data contained on the form to facsimile machines at remote locations or to other remote devices such as a hospital's computer, a clinic's computer or a manufacturer's computer.